McMillan 2007.

Study characteristics
Methods	Design: RCT (patient and caregiver) Methodological quality: 2.5/6a (EPOC RCT/CCT checklist)
Participants	Country and regions: US, Tampa, Florida, metropolitan area Recruitment (1999‐2003, 50 months): sample drawn from large non‐profit community‐based hospice face sheets; consecutive new cancer patients aged ≥ 18 years living in study county, with a caregiver and problems with at least 2 symptoms (pain, breathlessness, constipation). Exclusion criteria: patient low level of consciousness (assessed by admission team), excessively debilitated (≥ 40 score on Palliative Performance Scale) or actively dying, admitted to inpatient hospice or assisted‐living facility or nursing home; patient and caregiver < sixth grade education, unable to read or understand English, ≥ 7 in Short Portable Mental Status Questionnaire, caregiver in active treatment for cancer themselves Number of patients (randomised): 329 (111 intervention, 109 control1, 109 control2) Diseases: cancer (329) Patient characteristics: mean age 70.84 years intervention, 71.02 years control1 and 70.12 years control2; 39.9% female Number of caregivers (randomised): 329 (111 intervention, 109 control1, 109 control2) Caregiver characteristics: mean age 63.06 years intervention, 61.53 years control1, 59.98 years control2; 85.4% female Deaths at end of study: not stated  Withdrawals/other drop‐outs: "Most commonly, attrition was due to patient decline (29%) or death (21%), and the caregiver feeling overwhelmed (23%), which was largely associated with patients' worsening condition"
Interventions	Reinforced vs. standard home palliative care (2 control groups) Additional component: "COPE Intervention" Type: specialist palliative care Service base: large non‐profit community‐based hospice  Team: additional component delivered by newly hired nurses (1 full‐time and 1 back‐up) and home health aides with hospice experience; 4 day training on intervention with role‐play; composition of standard home hospice care team not stated (cared for 850 patients/day) Responsibility: for additional component – nurse; for standard home hospice care team – not stated Description: home hospice care with new additional brief psychoeducational support (COPE intervention); caregiver problem‐solving education component grounded on conceptual and research literature on stress process models and problem solving training and therapy; 9‐day intervention with 3 visits (first 45 minutes, second and third 30 minutes) and continued support in between with calls to assess problems, offered support and answer questions and nurse pager contact; intervention adapted to teach a problem‐solving method to assess and manage patient symptoms (focus on pain, dyspnoea and constipation); 4 components: Creativity (viewing problems from different perspectives to develop new strategies for solving caregiving problems, e.g. distract patient from pain); Optimism (positive but realistic attitude towards problem‐solving process, including communicating realistic optimism to patient by showing understanding and hope and involving them in planning as much as possible; Planning (setting reasonable caregiving goals and thinking out, in advance, the steps necessary to reach those goals, e.g. family holiday); Expert information (what family caregivers need to know about nature of problem, when to get professional help, and what they can do on their own to deal with problem, e.g. where to get help); Home Care Guide for advanced cancer (for patients and caregivers) with 23 patient problems with easy reference for caregivers; caregivers encouraged to use the assessment scales for pain and dyspnoea at least twice daily and constipation scale at least daily and record findings in patient symptom diary – ratings were foundation for action to call hospice staff and manage symptoms at home; intervention manual (available from authors) and audiotapes of sessions reviewed monthly to ensure protocols were followed Duration: 9 days for additional component; duration of standard home hospice care not stated but likely to be from admission to death Control: control1 ‐ standard specialist home hospice care with additional supportive visits from intervention nurse and home health aide (same visit frequency and length as intervention); nurse provided individual caregiver support, discussed feelings, fears, and relationship with patient; trained not to give advice about managing problems and not to teach structured problem‐solving skills (e.g. dealt with questions asking about advice given by hospice nurse); manual and audiotapes of sessions reviewed monthly to ensure protocols were followed; home health aide provided respite staying with patient during supportive visits; control2 ‐ standard specialist home hospice care, which included some caregiver education and support about symptom management and what to expect with disease progression
Outcomes	Caregiver pre‐bereavement outcomes (3 primary outcomes ‐ quality of life, burden, mastery; distress with patient symptoms, coping)  Physical symptoms (pain, breathlessness and constipation) Symptom distress Quality of life Assessment points: at baseline, 16 days after baseline (1 week post intervention) and 30 days after (2 weeks post intervention) Analysis: forwards from enrolment
Resource use/costs	Not assessed
Notes	Power considerations: based on power calculations, 160 patient‐caregiver dyads were sought for each group (n = 480) Authors discussed challenges of recruitment in methodological paper: large amount of time spent screening face sheets (to bypass nurse gatekeeping) for very low proportion of eligible patients (5%), need to delay recruiting from 24 up to 48 hours after hospice care admission (to avoid time of transition and opt out of curative treatment), attrition due to decline and death (69% 30 days after baseline); this led to extension of recruitment period, problems with generalisability and adjustments to study budget
Risk of bias
Bias	Authors' judgement	Support for judgement
Concealment of allocation (RCT / CCT)	Low risk	"randomly assigned to the three treatment conditions at baseline by using a computerized randomization procedure by telephone"
Follow‐up (RCT / CCT)	High risk	42 intervention (38%), 47 control1 (43%), 60 control2 (55%) at 16 day follow‐up; 31 intervention, 32 control1, 40 control2 at 30‐day follow‐up
Blinding (RCT / CCT)	Unclear risk	Single‐blind: self completed questionnaires administered without offer of information or assistance; "research assistants were blind to treatment conditions and had contact with intervention staff only at regularly scheduled staff meetings where individual cases were not discussed"
Baseline measurement (RCT / CCT)	Unclear risk	No significant sociodemographic differences in patient and caregiver characteristics (P value > 0.10); outcome baseline data not reported
Reliability of outcome measurement (RCT / CCT)	Unclear risk	Self completed questionnaires administered by blinded research assistants (see above); caregivers overestimated symptom intensity for pain (the difference in mean scores was 1.33 in a 0 to 10 scale), breathlessness (0.78 difference in mean scores in a 0 to 10 scale) and constipation (1.08 difference in mean scores in 0 to 16 scale); all 3 differences were very significant (paired t‐tests; P value < 0.001). Pearson correlation coefficients were 0.40, 0.46 and 0.51, respectively
Protection against contamination (RCT / CCT)	High risk	Patients/caregivers randomised